RecruitingRare disease

Pharmacokinetics and safety of subcutaneous vs intravenous human normal immunoglobulin in adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on Chronic Inflammatory Demyelinating Polyradiculoneuropathy, a rare disorder in which the body's immune system attacks the protective coating of nerves, leading to muscle weakness and numbness. The trial compares two forms of human normal immunoglobulin therapy: an intravenous solution called Gamunex® 10% that is given through a vein, and a subcutaneous injection called Xembify that is placed under the skin. The purpose is to determine whether the weekly injection provides a similar level of the protective protein IgG in the blood as the less‑frequent infusion.

Participants receive the subcutaneous injection of Xembify once a week at a dose based on body weight, while a separate group receives the Gamunex® 10% infusion once every three weeks. The study continues for up to 39 weeks, during which safety is monitored and blood samples are taken to see how the body processes each medication. Terms such as “subcutaneous” mean under the skin, and “intravenous infusion” means the medicine is delivered slowly through a needle placed in a vein.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
First dose administration
Receive the initial medication according to the assigned group. if assigned to the Gamunex‑C group, a solution containing human normal immunoglobulin is given by intravenous infusion (through a vein) at a dose of 1000 mg per kilogram of body weight. the infusion is performed in a clinical setting and usually takes several hours.
If assigned to the Xembify group, a solution containing human normal immunoglobulin is given by subcutaneous injection (under the skin) at a dose of 456 mg per kilogram (approximately 0.456 g/kg). the injection is administered in the clinic or may be self‑administered once weekly.
Step 2
Regular dosing schedule
Continue receiving medication for up to 39 weeks.
For the Gamunex‑C group, the infusion of 1000 mg/kg is repeated every 3 weeks (once in each 21‑day interval).
For the Xembify group, the subcutaneous injection of 456 mg/kg is repeated once each week (every 7 days).
Step 3
Clinic visits for monitoring
Attend scheduled clinic appointments that coincide with each dosing visit.
During each visit, health professionals will check vital signs, look for any side effects, and record any changes in symptoms.
Step 4
Blood sampling for pharmacokinetic analysis
Provide blood samples at designated times to measure the level of immunoglobulin G (IgG) in the blood.
Samples are taken before each dose (pre‑dose) to determine the lowest concentration during the dosing interval and at other times to calculate the overall exposure (area under the curve).
Step 5
Reporting adverse events
Inform the study staff of any new or worsening symptoms, such as fever, headache, injection site reactions, or other health concerns, as soon as they occur.
The study team will assess the seriousness of each event and decide if any action is needed.
Step 6
Study completion
After completing the 39‑week treatment period, attend a final visit for a comprehensive safety and effectiveness assessment.
Final blood tests and clinical evaluations are performed to summarize the overall results of the trial.

Who can join the trial?

6 criteria

Be 18 years old or older at the time of screening.
Be able to sign a written form that shows you agree to join the study (informed consent).
Have the condition called Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) or a similar form, as defined by the 2021 guidelines from the European Academy of Neurology/Peripheral Nerve Society.
Weigh 90 kg (about 198 lb) or less and need a dose of intravenous immune globulin (IGIV) that is between 0.3 and 1.0 g per kg of body weight every three weeks, with a total amount between 20 g and 90 g each dose.
Be stable on your current IGIV treatment, meaning you have not changed your CIDP medication or had a flare‑up that needed new treatment in the 12 weeks before screening and up to the time you are randomly assigned (clinically stable).
Be willing and able to follow the study’s treatment schedule and attend all required check‑ups for the entire study period.

Who cannot join the trial?

16 criteria

Having any other nerve disease (called polyneuropathy) besides CIDP, such as multifocal motor neuropathy, hereditary nerve disorders, diabetic nerve damage, or nerve problems caused by medicines or toxins.
Having serious kidney problems, including large amounts of protein in the urine (proteinuria), a condition called nephrotic syndrome, acute kidney failure, being on dialysis, or blood tests showing very high waste levels (blood urea nitrogen or creatinine) indicating severe kidney impairment.
Having liver enzyme levels (called AST or ALT) that are more than 2.5 times the normal upper limit, indicating possible liver damage.
Having low blood‑cell count, specifically a hemoglobin level below 10 g/dL, which means anemia.
Currently taking blood‑thinning medicines that could make the study drug unsafe, such as warfarin, newer oral anticoagulants (e.g., dabigatran, rivaroxaban, edoxaban, apixaban), or injectable blood thinners (e.g., fondaparinux).
Having a condition called hyperviscosity syndrome, where the blood becomes too thick.
Having a known infection with HIV, chronic hepatitis B, or chronic hepatitis C.
Being enrolled in another clinical trial within the past 30 days or within five half‑lives of the other study’s medication.
Having severe illnesses that could affect the study, such as active cancer or a bone‑marrow transplant, serious heart problems (advanced heart failure, cardiomyopathy, dangerous heart rhythm, unstable heart disease, severe high blood pressure), advanced kidney disease (stage IV or V), conditions that weaken the immune system (like certain blood cancers, chronic low white‑blood‑cell count, or HIV), known bleeding disorders, severe skin disease at the injection site, or a history of alcohol, drug, or medication abuse.
Having a history of blood‑clot problems, including deep‑vein thrombosis, a tendency to clot excessively, heart attack, lung clot (pulmonary embolism), or stroke.
Having known severe allergic or adverse reactions to blood products, such as intolerance to high‑dose IV immune‑globulin, hemolysis (breakdown of red blood cells) after IVIG, aseptic meningitis, severe headaches, or serious skin reactions.
Having a CIDP relapse that needed a change in treatment within 12 weeks before the screening visit or between screening and randomization.
Having taken certain immune‑modulating drugs recently: alemtuzumab or rituximab within the past year; cyclophosphamide, interferon, TNF‑alpha inhibitors, fingolimod, or FcRn blockers within the past 6 months; plasma exchange or complement inhibitors within the past 3 months; or changes to methotrexate, azathioprine, mycophenolate, or other immunosuppressants within the past 6 months. Also, taking high‑dose steroids (20 mg or more of prednisone‑equivalent per day) excludes participation.
Needing an IV immune‑globulin dose that is either higher than 1 g/kg every 3 weeks, lower than 0.3 g/kg every 3 weeks, more than 90 g every 3 weeks, or less than 20 g every 3 weeks.
Being IgA deficient and having antibodies against IgA, which can cause severe reactions to the study drug.
For females who could become pregnant: being pregnant, having a positive pregnancy test, breastfeeding, or not agreeing to use a highly effective birth‑control method (such as hormonal pills, patches, rings, injections, implants, intrauterine device, condoms with spermicide, male sterilization, or true abstinence that matches their normal lifestyle) for the entire study period.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Clinirem Sp. z o.o.
Verified
Lublin, Poland
EMC Instytut Medyczny S.A.
Verified
Poznan, Poland

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Investigated drugs

Gamunex® 10%
is a solution of normal human immunoglobulin that is given through an IV (intravenous) infusion. In this study it is used as the standard treatment to compare against the new product. Participants receive it every three weeks, and the researchers look at how the drug behaves in the body and how safe it is for people with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Xembify
is a solution of normal human immunoglobulin that is injected under the skin (subcutaneous injection). It is the new product being tested in the trial. Participants receive it once a week, and the study measures its blood levels over time and checks for any side effects, comparing the results to those seen with Gamunex® 10%.

Human Normal Immunoglobulin

What is already known about the treatment

Gamunex® 10%, 100 mg/ml, solution for infusion
This medication is given by slow intravenous infusion, delivering the drug directly into a vein. It is an approved human normal immunoglobulin that is widely used and well described in medical literature. It is mainly used to replace missing antibodies in immune‑deficiency disorders and to treat chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The product works by supplying normal IgG antibodies, which help balance the immune system and reduce harmful inflammation; it belongs to the class of intravenous immunoglobulins (IVIG).
Xembify 200 mg/ml roztok pro subkutánní injekci
This medication is injected under the skin (subcutaneous injection) in a small volume that the body absorbs gradually. It is a commercially available human normal immunoglobulin that is well documented for use in immune‑deficiency conditions and CIDP. Its primary purpose is to provide IgG antibodies to support the immune system and lessen the nerve inflammation seen in CIDP. It works by adding normal IgG to the bloodstream, which modulates immune activity, and it is classified as a subcutaneous immunoglobulin (SCIG).

Investigated diseases

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - It is an immune‑mediated disorder that attacks the protective covering (myelin) of peripheral nerves. Symptoms develop gradually over weeks to months, often beginning with weakness and tingling in the arms and legs. Nerve function may fluctuate, showing periods of worsening followed by partial improvement. As the disease progresses, patients may experience increasing difficulty walking, maintaining balance, and performing fine motor tasks. The condition is chronic because it persists for at least eight weeks.